FDA.reportPublic FDA data

toothpowder

Manufacturer
Yangzhou Hongshengding Chemical Co.,Ltd.
Effective date
2018-01-06
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:54:00

Label at a glance#

Producttoothpowder
Active ingredientSODIUM FLUORIDE
Label structure6 sections

Indications and uses

helps protect against cavities.

Dosage and administration

Adults and children 2years of age and older:Brush teeth thoroughly,preferably after each meal or at least twice a day,or as directed by a dentist or a physician. Children 2-6 years:Use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing) Children under 2 years:Ask a dentist or a physician.

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Sodium Fluoride 0.24%(0.1 w/v Fluoride ion)

Purpose

OTC - PURPOSE SECTION

anticavity

Uses

INDICATIONS & USAGE SECTION

helps protect against cavities.

Warnings

WARNINGS SECTION

Keep out of the reach of children under 6 years of age.if more than used for brushing is accidently swallowed,get medical help or contact a Poison Control Center immediately.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 2years of age and older:Brush teeth thoroughly,preferably after each meal or at least twice a day,or as directed by a dentist or a physician.

Children 2-6 years:Use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)

Children under 2 years:Ask a dentist or a physician.

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

calcium carbonate,silica,mint falvour,sodium laryl sulfate ,sodium benzoate

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1122

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71035-500-012020-01-31C16284748780-19d75b9d0-4381-f424-e053-dadaa90a57ceCharm-Tex toothpowder
71035-500-022020-01-31C16284748780-19d75b9d0-4381-f424-e053-dadaa90a57ceCharm-Tex toothpowder
71035-500-032020-01-31C16284748780-19d75b9d0-4381-f424-e053-dadaa90a57ceCharm-Tex toothpowder

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71035-500-01toothpowder28 g in 1 BAGPOWDER282
71035-500-01toothpowder250 in 1 CARTONPOWDER2502
71035-500-02toothpowder57 g in 1 BAGPOWDER572
71035-500-02toothpowder250 in 1 CARTONPOWDER2502
71035-500-03toothpowder250 in 1 CARTONPOWDER2502
71035-500-03toothpowder85 g in 1 BAGPOWDER852

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71035-500TOOTHPOWDER (SODIUM FLUORIDE) POWDER [YANGZHOU HONGSHENGDING CHEMICAL CO.,LTD.]2Legacy NDC, 6 package rows20180108_3f4d9559-9f32-2552-e054-00144ff8d46c.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71035-50071035-500-03, 71035-500-02, 71035-500-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
CALCIUM CARBONATEH0G9379FGKIACT
SODIUM SILICATEIJF18F77L3IACT
MINTFV98Z8GITPIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM LAURYL SULFATE368GB5141JIACT
SODIUM FLUORIDE8ZYQ1474W7ACTIM

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
62175f7d-6be1-2fb8-e053-2991aa0adb4b3f4d9559-9f32-2552-e054-00144ff8d46c2018-01-06WarningsExact identifier
spl id: 62175f7d-6be1-2fb8-e053-2991aa0adb4b
spl set id: 3f4d9559-9f32-2552-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.